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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008093
Receipt No. R000008987
Scientific Title Phase 1 Clinical Trial of intra-thoracic administration of Zoredronic Acid in Subjects with Unresectable Malignant Pleural Mesothelioma
Date of disclosure of the study information 2012/06/04
Last modified on 2019/01/31

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Basic information
Public title Phase 1 Clinical Trial of intra-thoracic administration of Zoredronic Acid in Subjects with Unresectable Malignant Pleural Mesothelioma
Acronym Phase 1 Trial of Zoredronic Acid in Malignant Pleural Mesothelioma
Scientific Title Phase 1 Clinical Trial of intra-thoracic administration of Zoredronic Acid in Subjects with Unresectable Malignant Pleural Mesothelioma
Scientific Title:Acronym Phase 1 Trial of Zoredronic Acid in Malignant Pleural Mesothelioma
Region
Japan

Condition
Condition Malignant Pleural Mesothelioma
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 o establish the safety of intra-thoracic administration of Zoredronic Acid and to guide decision making for the effective dose
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes Evaluation of the incidence of the adverse effect and dose limiting dose(DLT)
Key secondary outcomes Anti-tumor effect (Response to the treatment)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Initial dose of 0.4mg of Zoredronic acid will be administered by injection into thoracic cavity. Thereafter, patients will be observed for at least two weeks to evaluate the adverse effects. Transition to the next cohort will be decided following the evaluation of the development of DLT. The dose will be gradually increased every three subjects from 0.4mg to 1mg, 4mg, 8mg, 12mg and 16mg respectively.Repeat injections for the same patient at the same dose are acceptable.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Patients with histologically or
cytologically documented malignant
pleural mesothelioma
Unresectable case(including recurrent case of post-operation)
Patients refractory to chemotherapy,
or those relapsed after therapies.
Patients who reject chemotherapy will
be also included.
ECOG Performance status 0 to 2
Life expectancy must be longer than 3 month from
the entry.
Patients who are free of marked
failure of major organ function, more
over the following criteria must be
satisfied in laboratory tests. WBC >=3000/mm3, neutrophil>=1500 /mm3, Hgb>=
8.0 g/dl, Plt >=100.000 /mm3, AST/ALT<=
100 IU/L, T-Bil<=1.5 mg/dl, Cre<=1.5
mg/dl Ccr >=60 ml/min , PaO2>= 60 mmHg or>=90% by pulse oxymetry
Informed consent must be obtained
Key exclusion criteria Patient with active multiple primary
cancer (synchronous multiple primary
cancer and invasive cancer of other
organs)
Patient with symptomatic brain
metastasis requiring any treatments
Patient underwent thoracic irradiation
therapy or pleurodesis (within a month).
Patient with interstitial pneumonia,
confirmed by clinical examination or
by chest CT scan
Patients with history of myocardial
infarction (MI) in recent 6 month, or
those with any risk of MI recurrence.
Patient with other severe medical
complications.
Patient with history of drug-related
allergy to zoredronic acid or other
bisphosphonate or those with AEs over
Grade 3 in CTCAE.
Patient with stomatognathic disease
(pulpitis, gingivitis,etc) requiring
invasive (surgical) treatment.
Patient who received chemotherapy for
mesothelioma, or those participated
other clinical trial for unapproved
drug with in a month.
Difficult to participate in the trial
because of psychiatric disorder or
psychiatric symptoms
Pregnant or lactating woman.
Ineligible to the trial based on
decision of an investigator, such as
poor compliance to follow up in the
clinical course.
Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Tada
Organization Chiba University Hospital
Division name Department of Respirology
Zip code
Address 260-5670 1-8-1 Inohana Chuo-ku Chiba, Chiba prefecture, Japan
TEL 81432227171
Email ytada@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuji Tada
Organization Chiba University Hospital
Division name Department of Respirology
Zip code
Address 260-5670 1-8-1 Inohana Chuo-ku Chiba, Chiba prefecture, Japan
TEL 81432227171
Homepage URL http://www.m.chiba-u.ac.jp/class/respir/index.html
Email ytada25@yahoo.co.jp

Sponsor
Institute Chiba University Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Chiba Cancer Center
Toho University Omori Medical Center
Tokyo Women's Medical University Yachiyo Medical Center
Name of secondary funder(s) none

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 千葉大学医学部附属病院(千葉県) Chiba University Hospital

Other administrative information
Date of disclosure of the study information
2012 Year 06 Month 04 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 03 Month 26 Day
Date of IRB
Anticipated trial start date
2012 Year 06 Month 01 Day
Last follow-up date
2018 Year 12 Month 24 Day
Date of closure to data entry
2018 Year 12 Month 24 Day
Date trial data considered complete
2018 Year 12 Month 24 Day
Date analysis concluded
2018 Year 12 Month 24 Day

Other
Other related information

Management information
Registered date
2012 Year 06 Month 04 Day
Last modified on
2019 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008987

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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